Laser-Assisted Laterally Positioned Flap Operation: A Randomized Controlled Clinical Trial For figures, tables and references we refer the reader to the original paper. Introduction During recent decades, several surgical procedures were proposed for correcting gingival recession defects with varying degrees of success. These techniques include pedicle flaps [coronally advanced flaps1 and laterally positioned flaps (LPF)],2 free soft tissue grafts,3 and combinations of these procedures. The LPF is primarily indicated for isolated recession defects on mandibular teeth.2,4 The tooth adjacent to the recession defect serves as the donor site for a flap that has been moved laterally to cover the recession defect.5 Previous studies reported a defect coverage ranging from 61% to 74% with a mean of 67% indicating partial success.5–10 The limitation of the technique to the sites with an adequate amount of adjacent keratinized donor tissue and possible postoperative recession at the donor site were considered to be the disadvantages of LPF.11,12 Currently, diode lasers are generally accepted and widely used as a tool for soft tissue management.13,14 The energy level of diode laser is absorbed by pigmentation in the soft tissues, making diode laser an excellent hemostatic agent for soft tissue surgeries.13 Other advantageous properties of diode lasers are relative ease of ablation of tissues, little wound contraction, minimal scarring, and less postoperative pain.14,15 Compared with a conventional scalpel, diode laser can cut, ablate, and reshape the oral soft tissue more easily, with no or minimal bleeding and little pain requiring no, or only a few, sutures.13–15 Therefore, in periodontal therapy, diode laser treatment may serve as a good alternative, especially for the fine cutting of soft tissues such as depigmentation, gingivectomy, gingivoplasty, and frenectomy.16 As it is important to achieve tension-free advanced flap for succesful clinical outcomes17,18 in routine periodontal plastic surgery techniques, attempts have been made to reduce this tension. Therefore, the purpose of the current clinical trial was to compare the effectiveness of a new treatment approach, which consisted of an LPF procedure combined with an external vestibular releasing incision, versus LPF alone, for the treatment of single gingival recession defects. In order to reduce the reported ecchymosis and edema, the external vestibular releasing incision was made by a diode laser (laser-assisted laterally positioned flap [LALPF]). The null hypothesis to be tested was that there would be no differences in clinical and aesthetic parameters between LALPF and conventional LPF for the treatment of gingival recession defects. Material and Methods This was a parallel, randomized, single-center, clinical trial. Isolated single Miller II gingival recession associated with minimal loss of interdental papilla was included in this trial.19 Sample size Sample size was calculated with the clinical parameter (gingival recession depth) estimate based on a a previous article.18 Assuming a minimum clinically significant value (d) is 0.5 mm with a 0.46 standard deviation for gingival recession depth, the minimum sample size was ∼16 in each study groups, within a 95% confidence interval and 80% power. Patient selection Thirty-two systemically healthy patients, 13 males and 19 females, ages 25–39 years, were enrolled in the study. The participants of this study were chosen among individuals who were referred to the Periodontology Department of Cukurova University between March 2011 and February 2012. The approval of the Local Ethics Committee of Cukurova University Faculty of Dentistry was obtained (IRB2010-4-3). All participants were informed about the study and signed an informed consent form in accordance with Helsinki Declaration principles. Inclusion criteria Miller class II deep and narrow isolated recession defects (≥5 mm in depth and ≤1.5 mm in width) with minimal interdental papilla loss (distance between contact point and papilla tip ≤2 mm) on lower incisors were included in this study (Fig. 1A–C). The inclusion criteria were: presence of identifiable cementoenamel junction (CEJ); presence of a step ≤2 mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ; a full-mouth plaque score of <10%;20 no occlusal interferences; periodontal and systemic health; no contraindications for periodontal surgery; and not taking medications known to interfere with periodontal tissue health or healing. All patients were nonsmokers. Randomization Patients were allocated to one of the two treatment groups using a computer-generated randomization table. Sixteen patients were assigned to the test group (LALPF), and the other 16 patients were assigned to the control group (LPF alone). Initial therapy and clinic measurements In both groups, a session of prophylaxis was performed, and coronally directed roll technique was prescribed for teeth with recession to eliminate traumatic tooth brushing habit related to the etiology of the recession.18,21 The criterion for surgery was optimal plaque control with a full mouth plaque score of ≤10%.22 The gingival23 and plaque index24 were used to assess gingival health conditions throughout the study. At the baseline and 6 months after surgery, the following clinical parameters were recorded to the nearest millimeter:3,25 (1) gingival recession depth (GRD), measured as the distance between the most apical point of the CEJ and the gingival margin (GM); (2) gingival recession width (GRW), measured as the distance between the mesial gingival margin and the distal gingival margin of the tooth (measurement was recorded on a horizontal line tangenital at the CEJ); (3) probing depth (PD), measured as the distance from the GM to the bottom of the gingival sulcus; (4) clinical attachment level (CAL), measured as the distance from the CEJ to the bottom of the sulcus; (5) apicocoronal width of keratinized tissue (KTW), measured as the distance from the mucogingival junction (MGJ) to the GM, with the MGJ location determined using a visual method;25 (6) recession depth reduction; (7) mean root coverage (MRC); and (8) complete root coverage (CRC). CRC was calculated according to the formula of Zucchelli et. al., and the defects with a score of 100 were considered as completely covered.26 The measurements were performed using a UNC-15 periodontal probe. Intraexaminer reproducibility One examiner, who was blinded to the surgical procedures, performed the clinical measurements and also assessed all patient related outcomes of treatments (M.C.H.). The examiner evaluated 20 patients with Miller class II recession defects that were not involved in the study, on two occasions (24 h apart). Calibration was accepted if 90% of these recordings could be reproduced within a difference ≤0.5 mm.27 Control group (LPF technique) All surgical interventions in the test and control groups were performed by the same periodontist (E.Y.) in order to prevent interoperator variations. The LPF procedure used in the control group (Fig. 2A) was a modification of the surgical technique described by Grupe.12,28 Briefly, a reverse bevel incision was made along the soft tissue margin of the defect for the removal of the pocket epithelium. At ∼3 mm from the wound edge, which delineates the defect at the side opposite the donor area, a superficial incision was made extending from the gingival margin to a level ∼3 mm apical to the defect. Another superficial incision was placed horizontally from this incision to the opposite wound edge. The epithelium and outer portion of the connective tissue within the area were removed by sharp dissection. In this way, a recipient bed was created at the one side of the defect. A tissue flap to cover the recession was then dissected in the adjacent donor area. The preparation of this flap was initiated by a vertical superficial incision parallel to the wound edge of the recession and at a distance, which exceeded the width of the recipient bed ∼3 mm. This incision was extended beyond the apical level of the recipient bed and was terminated within the lining mucosa with an oblique releasing incision directed toward the recession site. An incision connecting the vertical incision and incision previously made around the recession were placed ∼3 mm apical to the gingival margin of the donor site. A split thickness flap was then prepared by sharp dissection. Deepithelialization of the facial soft tissue of the interdental papilla was performed by scalpel. The prepared tissue flap was rotated ∼90 degrees and sutured at the recipient bed. Test group (LALPF technique) The diode laser (810 nm) was applied first in the test group (Fig. 3A and B). An external horizontal releasing incison on the vestibular alveolar mucousa was made with diode laser (3 W, continuous mode). The laser incison was started ∼5 mm apically from the recession defect and extended superficially to the distal of the donor teeth (Fig. 3C). This incision provided a very fine partial dissection of the mucousa removing all tension from muscle and/or frenum attachments and at the same time preserving partial blood supply to the flap. Then the recipient site and donor tissue were prepared, laterally positioned, and sutured as in the control group (Fig. 3D–F) with the exception that de-epithelialization of the interdental papilla was also performed by diode laser in the test group. In both groups, the interrupted periosteal 5-0 sutures (Ethicon, Johnson & Johnson nylon monofilament) were used for close adaptation of the pedicle graft to the underlying recipient bed. At the end of the surgery, periodontal dressing was applied. Postsurgical protocol The patients were prescribed ibuprofen as needed. All patients were instructed to abstain from brushing and flossing around the surgical area until suture removal. The sutures and periodontal dressing were removed 7 days after surgery. Plaque control in the surgically treated area was maintained by chlorhexidine (0.12%) rinsing for an additional 2 weeks (Fig. 3G and H).29 After this period, patients were reinstructed in mechanical cleaning of the treated tooth. All patients were recalled once every 2 months, until the final examination (Fig. 2B and Fig. 4A and B).21 Patient evaluation of postoperative condition and aesthetics Data on perceived hardship of procedure was measured by VAS (VAS-H) (0 indicating easy to cope, 100 indicating difficult to cope) with scores from 0 to 100.30 The postoperative discomfort and aesthetics were evaluated by the patients on a 100 mm VAS.20 The questionnaire was divided into two parts: the first part, regarding the postoperative morbidity and pain, was completed 1 week after surgery (VAS-P) (0 indicating very bad, 50 indicating average, and 100 indicating an excellent postoperative course), and the second part, concerning patient satisfaction with the aesthetic outcome, was completed at the 6 month follow-up (VAS-E) (0 indicating very bad, 50 indicating average, and 100 indicating excellent).20,31–34 Evaluation of clinical aesthetic outcomes The aesthetic evaluation was performed according to the root coverage aesthetic score system (RES), published by Cairo et al.35 Five variables were evaluated, which included; GM, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the GM, whereas a score of 0 or 1 point was used for each of the other variables. Statistical analysis Data analysis was performed using SPSS software (version 19.0 for Windows; SPSS Inc, Chicago, IL). Nonparametric tests were chosen for continuous variables, as the data were not distributed normally. Comparisons between groups were applied by using the Mann–Whitney U test. Time dependent data were analyzed by Wilcoxon's signed rank test. Differences (Δ) between baseline and the 6th month were calculated. The categorical variables between the groups were analyzed by using the χ2 test. Results were presented as mean±SD and median (min-max), n, and %. A p<0.05 was considered as significant. Results Sixteen patients were treated in each group. However, there was one dropout in the LPF group; this patient could not comply with the study schedule. The data of the patient were not included in the statistical analysis. Postoperative healing of patients was uneventful. The baseline patient-related characteristics are summarized in Table 1. No statistical differences were observed between groups for any measurements at baseline (Table 2). Statistically significant differences of GRD, CAL, PD, and KTW between baseline and 6 months were observed within each group (p < 0.0001). The analysis of the mean differences of the clinical parameters between baseline and 6 months (Δ) showed significant differences between groups for GRD, CAL, and KTW (p < 0.001, p < 0.018, p < 0.026, respectively) (Table 2). Thirteen of the 16 defects in the LALPF group (81.2%) and 7 of the 15 defects (46.7%) in LPF group exhibited CRC (Table 3). At the 6 month follow-up examination, the mean root coverage scores were 75.7% for the control group and 92.5% for the test group. There was no difference of data from immediately after surgery on perceived hardship of procedure between groups (VAS-H). VAS-P measurements between the treatment groups in the 1st postoperative week showed no statisticaly significant results. Patient satisfaction with aesthetics was higher in the LALPF group than in the LPF group (p < 0.041). Patient-based aesthetic results were also compatible with the clinical measurements indicated by RES values (p < 0.001) (Table 4). Discussion The null hypothesis, that there would be no differences in clinical and aesthetic parameters between LALPF and conventional LPF for the treatment of gingival recession defects, was rejected. The results of the study showed significantly better outcomes in the LALPF group for GRD, CAL, and KTW. In the literature, the reported mean percentage of root coverage ranges between 34% and 82% for LPF procedures.6,7,9,10,36–41 Only one study reported data on the percentage of CRC, and showed CRC percentages between 40% and 50%.42 In the present study, CRC was 81.2% for the LALPF group, which is higher than in most previous studies.6,7,9,10,36–41 This finding can be explained by the decrease in the flap tension and by some advantages of laser use. Flap tension has been reported as a key factor in the surgical treatment of gingival recessions.17,43,44 Pini Prato et al.17 have reported that higher flap tensions (4–11 g) before suturing were associated with lower recession reduction whereas minimal tensions (0–4 g) were often associated with CRC.17 Rotated flap procedures, especially LPF, could increase the flap tension, which might jeopardize the initial wound healing and result in less favorable results. The external vestibular laser incison used in this study was more advantageous, probably because this technique allowed a more passive and completely relaxed flap than the conventional LPF. Flap tension caused by movement of the lips and buccal mucosa was relieved nontraumatically by the laser in the test group. Another benefit of the external vestibular incison was the maximum enhancement and augmentation of the donor tissue by decreasing the apical pull. The use of laser enabled precise vestibular deepening incisions, which freed the pedicle flap, allowing the clinician to maneuver the tissue more properly. The increase in the amount of advancement or mobilization of the pedicle flap (without tension) is directly related to the clinical success. The surgical procedure reported here also provided the maximum lateral and coronal positionings of the flap; these positionings were reported previously as one of the key factors for CRC.18,32,44 Butler has used a similar vestibular releasing incison with a scalpel during gingival recession treatment, and reported significant postoperative ecchymosis and edema related to this incison.45 In contrast, none of the patients in our test group had similar complaints, probably because of the advantages of lasers. Soft tissue surgery is one of the major indications for lasers. Laser surgery can be superior to conventional blade surgery because ablation, decontamination, and hemostasis are easier to achieve, and there is potentially less operative and postoperative pain. However, possible damaging thermal effects to the underlying tissues should be kept in mind when using lasers deep in the tissues. It is well documented that the scattering of laser energy within the surrounding tissues is low, and the layer of heat-altered tissue that remains after vaporization is relatively shallow.46 As diode lasers have an excellent soft tissue ablation capacity, a precise and nontraumatic deepithelization was performed by the laser in the test group. An attempt was made to completely remove the epithelium, while retaining as much of the lamina propria as possible, which is more difficult to do with scalpel. In addition, the laser-assisted technique used here may shorten the duration of treatment by enabling three operations such as LPF, frenectomy, and vestibuloplasty in single session. Other advantages of the use of a diode laser include a relatively bloodless operative and postoperative field, less traumatic operation, greater accuracy in making incisions (especially for vestibular deepening and frenectomy operations), sterilization of the surgical field, minimal swelling and scarring, vaporization, and cutting with much less postoperative pain. This could provide potential advantages for the surgery, the healing process, and the patients' perceptions of the procedure. The surgery can be less invasive, take less time, and be less demanding; the healing process could be favored by the improved wound stability of minimally mobilized flaps; and the patients could benefit from a procedure with potentially reduced intra- and postoperative morbidity. Lasers have also been known to stimulate growth factors, which enhances the activation of human gingival fibroblasts and periodontal ligament cells to proliferate and release growth factors in tissues; therefore, this may have also had an impact on our positive findings for the laser therapy.47 Kerner et al. reported that aesthetics was the main reason for the root coverage procedures, whereas root sensitivity and soft tissue augmentation accounted for only 27.35% and 10.81%, respectively.33 CRC, good color blending of the treated area, irregular tissue texture, or inadequate contiguity with adjacent soft tissues may affect the aesthetic perception of treatment.31,48,49 In addition, Kerner et al. reported that soft tissue appearance is more important than the quantitative level of root coverage, and that the colorimetric integration is the most important parameter when dealing with aesthetics.49 The patients treated with LALPF technique were more satisfied aesthetically than the patients treated with LPF. Another evaluation was performed by using the RES to investigate the aesthetic outcomes according to MTC, STT, MGJ alignment and GC. The findings of this evaluation were in accordance with the patientcentered assessment results, which showed that the patients treated with LALPF had better RES scores than did the LPF group. Limitations The present study has some limitations. The first one is inherent to the follow-up period. As this is a short-term assessment of the comparison of LALPF with LPF, the evaluation period used in this study was 6 months from the last surgical treatment. Although this period is considered adequate to provide soft tissue maturity and stability as reported in systematic reviews dealing with root coverage procedures,50,51 it was shown that the length of follow-up is a positive predictive factor in terms of aesthetics, and that the follow-up period should not be <12 months.49 Although diode laser does have advantages in the management of LPF operation, the long-term benefits of its use in mucogingival procedures need to be established. Further work in this area is required to assess whether these initial positive results are modified over time. Another limitation is inherent to the sample size. As the inclusion criteria of the patients were strict and it was hard to find a sufficient number of patients with isolated gingival recession, this study was only able to include the minimal sample size. Conclusions In conclusion, this randomized controlled clinical trial showed that the use of a diode laser for performing/creating an additional vestibular releasing incision during LPF had positive effects on clinical and aesthetic outcomes in treating isolated gingival recessions. Although diode lasers may have some advantages in the management of LPF operation, the long-term benefits of its use in mucogingival procedures need to be established. Further work in this area is required to assess whether these initial positive results are modified with time.